A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males

A Randomized, Open Label, Four Period, Cross-Over Study to Evaluate the Pharmacokinetics of Single Doses of Various TRV734 Formulations in Healthy Male Subjects

The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: TRV734

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy as determined by a responsible physician or trained qualified designee
• Males: 18 - 55 years inclusive at screening
• Capable of giving written informed consent

Exclusion Criteria:

• Clinically significant conditions or history of fainting or syncope
• Medical or psychiatric illness that could interfere with the completion of treatment and follow up
• Major surgery within 4-weeks of screening
• Known difficulty with obtaining intravenous access
• History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation
• Use of prescription or non-prescription medications
• History of excessive alcohol use
• History of drug abuse within 6 months of screening
• Use of any illegal drug within 30 days of screening and throughout participation in the study
• History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
• Donation of blood or plasma 4 weeks prior to dosing
• Participation in a clinical trial and has received medication within 30 days
• Weight <50 kg or BMI outside range of 18-32 kg/m2
• Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
• Unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of child-bearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Formulation A	Drug: TRV734; Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.
Experimental: Formulation B	Drug: TRV734; Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.
Experimental: Formulation C	Drug: TRV734; Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.
Experimental: Formulation D	Drug: TRV734; Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.
Experimental: Formulation E	Drug: TRV734; Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.
Experimental: Formulation F	Drug: TRV734; Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the maximum observed plasma concentration (Cmax)	9-days
Evaluate the time at which the maximum plasma concentration was observed (tmax)	9-days
Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)	9-days
Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)	9-days
Evaluate the apparent elimination half-life (t1/2)	9-days
Evaluate the apparent clearance (CL/F)	9-days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability as measured by adverse events	9-days
Safety and tolerability as measured by clinical observations	9-days
Safety and tolerability as measured by 12-lead ECGs	9-days
Safety and tolerability as measured by cardiac telemetry monitoring	9-days
Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature)	9-days
Safety and tolerability as measured by oxygen saturation	9-days
Safety and tolerability as measured by safety laboratory tests	9-days

Collaborators and Investigators

• Sponsor: Trevena Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: April 3, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Healthy; Pharmacokinetics; Male
• Other Study ID Numbers: CP734-1003